Skip to main content
Clinical Trials/NCT03129659
NCT03129659
Unknown
Not Applicable

Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome With Inconclusive Diagnostic Work-up

Erasmus Medical Center2 sites in 1 country230 target enrollmentFebruary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Coronary Syndrome
Sponsor
Erasmus Medical Center
Enrollment
230
Locations
2
Primary Endpoint
Diagnostic accuracy of coronary CT angiography to identify patients with NSTE-ACS.
Last Updated
5 years ago

Overview

Brief Summary

Current evaluation of patients suspected of non-ST-elevation acute coronary syndrome is greatly dictated by the results of high-sensitivity troponins. In a substantial number of patients this approach does not provide a conclusive work-up. Patients typically present with slightly elevated high-sensitivity troponins without significant changes during serial sampling and no other clinical clues that can aid in determining the etiology of their chest pain complaints. Uncertainty remains about the optimal diagnostic management of these patients and they are often admitted to undergo invasive angiography. Coronary CT angiography can improve efficiency of clinical care in these patients by reducing unnecessary hospital admissions and invasive angiography. In this study, the investigators will investigate whether a diagnostic strategy comprising of early coronary CT angiography is more clinically efficient than standard optimal care in patients with an inconclusive work-up for non-ST-elevation acute coronary syndrome.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
September 1, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Admir Dedic

Principal Investigator

Erasmus Medical Center

Eligibility Criteria

Inclusion Criteria

  • Patients presenting to the emergency department with symptoms suggestive of NSTE-ACS. They do not fulfil criteria for either "rule-in" or "rule-out" NSTE-ACS based on serial sampling of high-sensitivity troponins and standard clinical work-up.

Exclusion Criteria

  • Inability or unwillingness to provide informed consent.
  • History of proven CAD, defined as documented prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft surgery.
  • Previous examination with either invasive angiography or CCTA in the last 3 years.
  • Clinical instability: clinical heart failure, hemodynamic instability, severe chest pain.
  • CCTA-specific contra-indications:
  • Allergy to iodine contrast media
  • Pregnancy
  • Impaired renal function: estimated glomerular filtering rate \<60% of the age-corrected normal values
  • Severe arrhythmia likely to affect image interpretation
  • BMI \> 40

Outcomes

Primary Outcomes

Diagnostic accuracy of coronary CT angiography to identify patients with NSTE-ACS.

Time Frame: 30 day

Sensitivity and specificity of coronary CT angiography for the diagnosis of NSTE-ACS.

Secondary Outcomes

  • Potential improvement of diagnostic accuracy with FFR-CT.(30 day)
  • Clinical characteristics of no obstructive coronary artery disease on CT.(30 day)

Study Sites (2)

Loading locations...

Similar Trials